Industry Trailblazers and the Fight for Health Freedom

Part One of a Seven-Part Series on Natural Success Stories

This story is dedicated to the memory of Rae Howard, cofounder of Good Earth Natural Foods
in Utah, who cared deeply about the passage and defense of DSHEA.

An October 3, 1994 headline in The Wall Street Journal spoke volumes: “Industry Hopeful for Deregulation of Vitamin Goods” (1). Just days before the passing of the Dietary Supplement Health and Education Act (DSHEA), critics of the proposed legislation—which represented everythingbut deregulation—were as outspoken as ever. Negotiations between the House and Senate were in full swing, making both sides feel lawmakers would come to an agreement on this monumental bill very soon.

Within a week, the newspapers had a different story to report, after DSHEA passed the House late on October 7, 1994. “Senate Swallows Hatch’s Remedy,” read The Salt Lake Tribune on October 9, 1994, proclaiming how Senator Orrin Hatch pushed through a compromise on “vitamin legislation vital to Utah’s huge health-supplement industry” (2).

Days later on October 13, The Santa Fe New Mexican reported, “Congress Passes Law Santa Feans Will Like.” The story described the role of Congressman Bill Richardson (D-NM) in moving along a bill that made important, but “endangered” health products now safe for sale. “The FDA won’t be able to just jerk supplements from the shelf on the grounds that it’s a useless waste of money…With the passage of this legislation, the FDA will have to prove that the stuff is bad for us before it’s banned,” the reporter wrote (3).

And by October 25 of that year, papers across the nation, such as the Chicago Tribune, were quoting President Bill Clinton’s sentiment that his signing of DSHEA into law would “bring common sense to the treatment of dietary supplements” (4).

DSHEA Basics

• Stands for the Dietary Supplement Health and Education Act of 1994.
• Introduced by Senator Orrin Hatch (R-UT) on April 7, 1993.
• Passed the Senate on August 13, 1994, and passed the House October 7, 1994. Signed into law (PL 103-417) by President Bill Clinton on Oct. 25, 1994.
• Reaffirms that supplements will be regulated as foods.
• States that ingredients in supplements are regulated as dietary supplement ingredients, either old (safe ingredients that were sold before Oct. 15, 1994) or new dietary ingredients (requiring FDA notification before their marketing).
• Preserves FDA’s right to take enforcement action against unsafe supplements. FDA burdened with proving products are unsafe.
• Requires “Supplement Facts” and other important information on labels.
• Upholds the expectation that supplements cannot make illegal health claims, as defined by the Nutrition Labeling and Education Act of 1990. Manufacturers are prohibited from making claims that products diagnose, treat, mitigate, cure or prevent a disease.
• Requires the substantiation of any claims of nutritional support, and the line, “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease” must accompany such claims on labels.
• Confirms that makers of dietary supplements must comply with current good manufacturing practices.
• Created the Office of Dietary Supplements.

It’s been nearly 20 years since the passing of DSHEA, and yet, the industry still has many lessons to learn about what it took to get the bill passed and how we can face opposition to health freedom in the future.

In the first of our seven-part series on Natural Success Stories, we highlight several Industry Trailblazers who worked tirelessly to help ensure health freedom through the passing of DSHEA, and who continue to stand up for the industry today.

The Straws that Broke the Camel’s Back
A storm had been brewing for several years before DSHEA came to be. In 1990, Congress passed the Nutrition Labeling and Education Act (NLEA), which gave the U.S. Food and Drug Administration (FDA) some additional backing to regulate supplements in new ways. NLEA allowed foods and supplements to make health claims on labels for the first time in history. But there was a big “if” associated with this. Companies could only make such lawful claims if there was “significant scientific agreement” and FDA pre-authorized it (5). While this is still the case today, the law was just vague enough that it gave the agency the wiggle room it needed to start aggressively coming after the supplements industry. All health structure/function claims were viewed as entirely the domain of drugs, and grounds for making supplements illegal for sale.

“FDA intended to regulate supplements as unapproved food additives and shut down as much of the industry as it could,” states Jarrow L. Rogovin, president and founder of Jarrow Formulas, Inc., Los Angeles, CA.

In the spring of 1992, an FDA task force committee released a report about dietary supplement regulation, noting that FDA should strictly enforce rules about supplements safety, create purity/identity standards, regulate amino acids as drugs and all others as food additives and pull anything illegal from shelves (6).

A few months later, in the summer of 1992, FDA demonstrated its might and its intent to remove supplements in a most dramatic way. Loren Israelsen, president of the United Natural Products Alliance, Salt Lake City, UT, takes us to the day that FDA raided Jonathan Wright, M.D.’s clinic. “It was holistic practice,” he says, referring to Wright’s “little doctor’s office” in a Washington State suburb. “Black jackets, SWAT teams, guns, came through the front door,” says Israel. “All of the patients got down on the floor with their hands behind their heads.” The offense? Giving B12 vitamin injections.

The whole escapade was caught on camera and made national headlines. “People were very outraged,” says Israelsen.

Not long after, Rae Howard, cofounder of Good Earth Natural Foods in Utah with her husband, Ken, brought a bill to Senator Orrin Hatch (R-UT) that she felt could protect supplements, and asked him to sponsor it in Congress (see page 38 for more). Senator Hatch didn’t hesitate, and introduced the Health Freedom Act of 1992, which attempted to stop FDA from abusing its regulatory power by using health claims as grounds for making supplements illegal. It was written on the premise that supplements are neither drugs nor food additives and the gray area in which they exist needed some fair parameters and definitions.

While Hatch’s version didn’t pass, he did get Congress to agree to the Dietary Supplement Act of 1992, which stopped FDA from applying NLEA’s labeling rules until the end of 1993. The bought time was much needed.

Meanwhile, the commissioner at the time, David Kessler, quietly created a committee with the goal of writing a report about how it felt supplements should be regulated.

“This was done in secret,” Israelsen remembers. “We began to hear that something was going on. We asked about it and were told that nothing was happening.”

But under pressure from industry, FDA finally published the Dykstra Report (officially named, “Proposed Rules for Food Labeling: General Requirements for Nutritional Labeling for Dietary Supplements of Vitamins, Minerals, Herbs or other Similar Nutritional Substance”) in the Federal Register in 1993.

“It said what we suspected it would, that most dietary supplements should be regulated as drugs,” said Israelsen. “FDA’s intentions were then crystal clear.”

Before long, there were even more seizures, with FDA going after more and more products, like the now infamous case of blackcurrant. FDA had no problems with blackcurrant in food form or as a liquid, but it was war against the oil in supplement form. Since the gelatin in the supplement was “food,” blackcurrant was considered to be a “food additive” in supplement form, and thus, the agency reasoned it should be pulled off the market (7). Costly legal battles ensued and blackcurrant became emblematic of FDA’s abuse of power.

Hope on the Horizon
All of this turmoil would have been enough to make many individuals throw up their hands and abide by FDA’s unfair policies, even if it meant losing an industry about which so many care deeply.

But, the natural/organic products community was not so easily discouraged. The difficulties only made industry fight harder and more creatively than ever before for the right to buy and sell supplements. And the tools it used in the battle are ones we should never forget, especially as industry fights to defend DSHEA today and tomorrow.

Grassroots fight. One of the most effectve weapons in the industry’s arsenal was the American people themselves. Gerald Kessler, founder and CEO, Nature’s Plus/Natural Organics, Inc., Melville, NY, called the public’s response “unprecedented” in the history of federal lawmaking. “It was this grassroots support that made the difference,” he states. “A federal law cannot stand if the people believe it is wrong.”

This didn’t just happen by chance. Jonathan W. Emord, principal of Emord & Associates, P.C., Washington, D.C., explains that it was a well-orchestrated plan to educate the public about FDA’s attempts to censor health information and block the sale of supplements. “When Citizens for Health, the American Preventive Medical Association (now Alliance for Natural Health-USA) and others joined with health food stores and caused millions of consumers to learn of FDA abuses of power and demand action from Congress, the foundation was laid for the passage of DSHEA,” he states. “Without that effort and public support, it is highly likely the bill never would have been voted out of committee, let alone passed.”

Retailers played a monumental role in all this. For instance, the late Joe Bassett, owner of Bassett’s Health Foods, Toledo, OH, helped mobilize shoppers through Citizens for Health, a group of which he was a cofounder. Meanwhile, Howard mobilized the NNFA to support the Health Freedom Act and, later, DSHEA, and used her store as a political hub to spread information.

And then there was a national Blackout Day. “The stores got together and draped all of their shelves with black cloth to signify that unless the public made their voices heard, the health food industry would cease to exist,” states Kessler. No one was allowed to buy supplements on Blackout Days, to simulate what it would be like if DSHEA didn’t pass. And, shoppers were encouraged to let Congress know how they felt about the situation. The response was incredible, both from consumers and from retailers who willingly took a financial hit to make it happen.

Shoppers heard the retailers’ message loud and clear. What happened next was an incredible letter-writing campaign to Congress. Elliott Balbert, founder and former president and CEO of Natrol, Inc., Chatsworth, CA, says it was “the second largest letter-writing campaign to Congress on any subject in U.S. history up until that time—second only to the opposition to the Vietnam War in the 1960s and 70s.”

This massive campaign resulted in more than 2.5 million pro-DSHEA letters being delivered to Congress. “That really got the attention of Congress and the attention of the prospective candidates,” says Balbert.

For this reason, Rogovin says independent stores made all the difference in the passing of DSHEA in 1994. But, he makes the observation that this may not be the same tool we could draw on today. “What made passing DSHEA possible and different from today is that there were small stores that had personal contacts with their customers,” he explains. “Unlike today’s corporate chains, the stores became very involved in this political fight and educated and recruited their customers to demand that Congress protect the industry from irrational and destructive regulation.”

This may well be the most important lesson of DSHEA. Says Kessler, “Individually, we can make a difference and collectively, we can make our voices and the voices of millions of Americans heard in Congress.”

Manufacturer involvement. Another huge part of getting DSHEA passed was heavy involvement from industry companies on the Hill. “On a personal level, I worked House and Senate offices three times and advocated very strongly for an idea I had, which was that there should be some sort of advisory board made part of the law,” says Rogovin. He explains how he, food and drug attorney Scott Polisky, and Katy Flamm, then co-owner of The Vitamin Trader of Albuquerque, NM, went to Congressman Bill Richardson to discuss Rogovin’s idea that eventually became the Commission on Dietary Supplement Labels (created by DSHEA). “The Commission laid down the initial guidelines and road map for the future once the bill was passed and signed by President Clinton,” said Rogovin.

Rogovin wasn’t alone in his involvement with lawmakers. As the grassroots effort mounted, several key manufacturers knew they needed to step up and make their voices heard. Says Balbert, “I remember walking through the halls of the House and the Senate with other leaders of supplements companies having one-on-one meetings with various Congressmen, and it was extremely effective.”

Some companies—many top supplements manufacturers that competed against one another on store shelves—even banded together to achieve a greater good. “The largest vitamin companies such as Nature’s Plus, Twinlab, Nature’s Bounty, Country Life and Solgar, joined forces under the newly formed umbrella, the Nutritional Health Alliance, and focused on the passage of DSHEA,” Kessler states. “I am proud that Nature’s Plus played the biggest role then and continues to protect the industry now.”

Kessler negotiated key aspects of DSHEA with lawmakers. He acknowledges the late Allen and Connie Skolnick, former owners of Solgar, for their part in these efforts. “They created a great company and as close allies, they were there for me when I called them from the floor of Congress to discuss last-minute changes we needed to make to the get the bill passed,” he states.

Manufacturers also counted on their trade organizations, like the National Nutritional Foods Association (NNFA, which today is the Natural Products Association), to guide them in supporting DSHEA. Balbert says one of the most successful industry fundraisers occurred at the July 1994 NNFA Convention in Las Vegas. The packed room was filled with 1,000 corporate personnel and some retailers, he says, many of whom lined up to make pledges as high as $50,000 to help lobbying efforts in Congress to get DSHEA passed.

Many credit the NNFA lawyers Robert Ullman, a partner in Ullman, Shapiro & Ullman, New York, and the late Milton Bass, with leading part of the fight for health freedom. For instance, before DSHEA, Bass was integral in the passing of the Proxmire Amendments in 1976, which guaranteed access to supplements. Together, Bass and Ullman fought numerous legal battles to preserve the right to buy and sell dietary supplements.

Kessler calls Bass “the greatest attorney this industry has ever had and the true grandfather of our great industry.” He goes on, “It was his dedication, energy and passion that forged this industry into one of the greatest industries in the world.”

Kessler explains that Bass fought for DSHEA in Washington, D.C., right until Congress broke session, which he says was “instrumental in the passing of DSHEA.”

Passionate lawmakers. Getting DSHEA to become law took important coordination with some key lawmakers, who went above and beyond in their support of the industry. “Getting our champions in the House, and especially the Senate, and having them use their capital is what did it,” says Balbert.

Israelsen was key in forging a pathway for industry to receive the help of Senator Hatch. “He had always expressed interest in the industry,” says Israelsen. “He had said over the years, ‘If you need help, I’m your Senator. I’m here. I stand ready to assist if you need me.’ So, one day, we went to him and said, ‘We need you.’”

Hatch fought hard with colleagues over DSHEA, working overtime to negotiate drafts of the bill and ensure his fellow lawmakers supported it.

Rogovin also singles out the role Congressman Richardson played to get House colleagues to pass the bill, particularly in convincing some staunch DSHEA opponents to see through the bureaucracy and advance the legislation. “One of the great turning points was the early morning hours, about 4:00 a.m., the last day of the Session of Congress, and Congressman Richardson called Representative Henry Waxman (D-CA) at his home and yelled at him to release the bill. Richardson carried the day for us,” Rogovin remembers.

In the end, after much political drama and deal making at the eleventh hour, DSHEA passed in the final minutes of the 1994 Senate Session.

DSHEA Today
Since the passing of DSHEA, industry has enjoyed much growth thanks to creativity and innovation from supplement makers. But, we have heard many times of late that the industry is being threatened, and that includes DSHEA.

“DSHEA is under attack from the usual suspects,” says Marc Ullman, partner in Ullman, Shapiro & Ullman, New York. He points to some offenders like Senator Dick Durbin (D-IL) and his colleagues, and also a segment of the mainstream media who like to write about dietary supplements being unregulated and in need of FDA preapproval. “What we need to do as an industry—and what our trades do really well, especially the Council for Responsible Nutrition and the American Herbal Products Association—is to respond to these attacks that they are flinging against supplements,” he says, adding, “Supplements are regulated. In fact, they are heavily regulated. While they may not be regulated as drugs, they certainly have a much more rigorous regulatory framework than ordinary foods.”

Other threats Kessler feels are chipping away at our health freedom are certain international agreements made with the United States. “Many other countries including Canada and Europe demand medicinal action of supplements to be proven or a product must be removed from the market,” Kessler states. “Certain forces are pushing the United States to adopt this invalid regulatory position. Supplements should be treated as foods, not as synthetic pharmaceutical drugs.”

FDA also seems to be have put a target on the industry’s back. One DSHEA provision, says Emord, allows supplement makers to promote supplements with independent scientific literature about the nutrient–disease relationship. “The FDA never adhered to this provision and has taken the position that even were the labeling exemption to apply to scientific literature used by a supplement company to sell its products, that literature could still be viewed as evidence of an intent by that company to sell its supplement illegally as an unapproved new drug,” states Emord. “That FDA ‘intended use’ doctrine has completely undermined the DSHEA labeling exemption.”

He also believes FDA has expanded its idea of implied drug claims to “constrict the meaning of the DSHEA provisions protective of structure/function claims.” And, FDA has used guidance documents like the proposed New Dietary Ingredients guidance to punch holes in DSHEA. For more on this issue, see sidebar, “Could 2014 be the Year of the Final NDI Guidance?”

When media, regulators and lawmakers attack the industry, Rogovin believes the problem is magnified because too few companies are committed to speaking out against them, like Ullman suggested. It takes time, commitment and money, which not many companies are willing to invest. “Too many companies think that somebody else can pay for the work and do the work and they will just profit from it and sacrifice nothing,” states Rogovin. “This is why the industry is on very shaky ground.”

Balbert agrees that lack of political contributions from industry is hurting us. “The dietary supplements industry and the natural products industry financially contribute a disproportionately small amount of their total revenue on an annual basis toward political activism on behalf of the industry,” he states. He explains he once analyzed the annual contributions given to trade groups and publically announced Political Action Committee (PAC) contributions. It came out to less that 0.1% of annual revenue. “How can you create a war chest and be effective if you won’t financially support it?” he asks.

Speaking of the lack of financial support, Rogovin adds, “This is a total travesty because we could easily be one of the most powerful voices in Washington because so many Americans take supplements.”

This could be an especially dangerous situation since some longtime defenders of the industry (Senator Hatch and Senator Tom Harkin [D-IA]) are scheduled to retire in the near future. For this reason, Kessler believes it’s time to be more active on the Hill again. “We need to fight for a Senate and Congress that understand that vitamins and health supplements are a benefit to the public and not something that needs burdensome government regulating. In fact, dietary supplements are the safest health-enhancing products available in the world,” he states.

Could 2014 Be the Year of the Final NDI Guidance?

One of the highest profile recent attacks against DSHEA may well have been the draft new dietary ingredients guidance, introduced in July 2011. Some believe FDA was trying to contort the NDI notification process set out in DSHEA into a premarket approval process that would cripple the supplements industry.

“This is another prime example of FDA overreach, where the agency has advanced a regulatory agenda that threatens to undermine much of what DSHEA was intended to accomplish. In one fell swoop, FDA aims at crushing innovation in the supplement market and locking manufacturers into dated means of production,” Jonathan W. Emord, principal of Emord & Associates, Washington, D.C., believes.

Industry is now waiting for a final guidance, but knows neither how it will read nor when it will surface. Experts interviewed for this piece, however, wager some guesses for what we can expect.

“I think we’ll see something this year,” says attorney Marc Ullman, partner in Ullman, Shapiro & Ullman, New York. “I think we need to get something from the agency to make clear what constitutes an NDI.”

How much FDA’s attitudes on NDI notification change from its draft is the big question. Jarrow L. Rogovin, president and founder of Jarrow Formulas, Inc., believes we shouldn’t get our hopes up for significant changes. “Given the current trajectory, which is an aggressive agency and a passive industry, expect another onerous draft guidance sooner rather than later… I expect FDA to lighten up on a couple of their intended throwaways, such as having to file an NDI Notification for every formula rather than for just a new ingredient.”

Emord doesn’t put much stock in a major overhaul, either. “I suspect that FDA will tinker with it around the edges but do almost nothing to change the substantive provisions to which industry objects,” he says.

Loren Israelsen, president of the United Natural Products Alliance, also thinks FDA will give on two of the five main objections raised by industry, but not on others. He predicts two major items will be “central to what happens next,” and they are the definition of chemically altered and whether synthetic materials can be dietary ingredients at all. “That will become a major point of discussion and debate,” he believes.

In the end, Rogovin believes the NDIs guidance could have an incredibly detrimental effect on the industry, if certain rules remain in place. “Depending upon how the FDA finalizes and enforces its NDI guidelines, enough products could end up removed from the market to put half the industry or more into bankruptcy,” he states.

The fight to defend the rights established in DSHEA isn’t just a battle to take to Congress; it must take place in the courts, too, believes Emord. Unfortunately, here too, he believes “industry has been lax in defending the plain and intended meaning of the law in court and in fighting to obtain new amendments to the law that will reverse FDA’s actions that undermine it.”

He doesn’t blame industry, really. Companies fear retribution from FDA if it is challenged. Emord himself has taken FDA to court several times on behalf of clients with the belief that FDA’s censorship of nutrient-disease relationship claims was unconstitutional—and won.

Emord believes the struggle is worth it: “That courage, so common in the nascent years of the industry and at the time of DSHEA passage, must be restored if the industry is to save itself from ever mounting, costly and, indeed, ruinous regulation. Without that courage, there is nothing to stand in the way of FDA’s near constant onslaught of new regulation which is making it all but impossible for innovation in the market and for many companies to survive.”

But perhaps the most critical risk of devaluing DSHEA, in Israelsen’s words, is the “failure of this industry to respect the principles of the law itself.”

By that Israelsen means companies that do not observe the basic, established rules of supplement manufacturing, and that includes having poor manufacturing standards, making claims that are clearly out of bounds, not filing new dietary ingredient notices and more. “If there’s a threat, that’s the threat,” he says.

In agreement is Rogovin, who says he is frustrated by “what many deadbeat fly-by-night frauds are claiming that is just plain illegal and making problems for the rest of us.”

While companies may feel the language with which they can talk about supplements is too limited, Ullman believes DSHEA still works and offers the industry protection. “People with a little creativity and some foresight can certainly be able to market in a compliant manner without feeling they are hamstrung by the inability to make drug-type claims for their products,” states Ullman.

Israelsen’s group has worked for years on the implementation part of the law, through education covering the gamut from good manufacturing practices to adverse event reporting, new dietary ingredients, analytical methods development, reference standards and more. “It’s made a difference,” Israelsen feels. “We know that in our membership, very positive FDA inspections result when companies invest in training staff, paying for expensive equipment, doing the auditing and becoming third-party certified. That all bears fruit, but not all companies do that. That’s our real challenge. We need a high common standard of compliance.”

There’s no good excuse for the slow implementation of these regulations. “If people are confused and don’t know the pathway for compliance, it’s not for lack of opportunity to learn how t­o do it right,” he states.

Adding to the problem, according to Rogovin, is that regulators and media are too busy condemning the entire supplements industry rather than diligently going after reckless offenders. “In terms of controlling claims, the FDA most recently is unilaterally altering long-established published regulations on information and this raises serious questions about the Administrative Procedures Act,” he states. “The other thing I find frustrating is what the FDA says about our industry that is not true and they should not be saying.”

Regardless of the challenges that face DSHEA going forward, the importance of supplements in individuals’ lives won’t change, and will fuel the industry’s fight to keep health freedom alive. DSHEA has gone down in history as an incredible success for a modest industry and the American public, and the story continues to go on as industry defends it moving forward. WF